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Patent Examination Guidelines – inventive step of a monoclonal antibody

Data:2021-06-20Author:Tiansong Zheng

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 In biopharmaceuticals, an antibody patent is one of the most valuable patents in the field. A claimed monoclonal antibody (see Table 1) can be defined as:

• an antigen or an epitope on an antigen to which the antibody is directed;
• a hybridoma producing the antibody; or
• amino acid sequences constituting the antibody.

It is preferable if the antigen to be directed by the claimed antibody is a novel and inventive one. If it is novel and inventive, a monoclonal antibody patent can be defined directly by the antigen and a patent claim with the broadest scope can be granted. If it is not novel and inventive, although an antibody can still be claimed by a hybridoma producing the antibody or amino acid sequences constituting the antibody, it will be unclear whether such a defined antibody can be considered to be inventive enough (see Table 2).

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Patent Examination Guidelines – inventive step of a monoclonal antibody